At issue were accusations of illegal marketing practices that allegedly involved the promotion of Boehringer products for indications the drugs did not carry regulatory approval. While doctors have the authority to prescribe drugs 'off label,' manufacturers have never been granted equal authority. Under government regulations, manufacturers may only promote and market drugs and medical devices for the indications upon which they were originally approved by the US Food and Drug Administration (FDA).
The qui tam lawsuit was brought by a former Boehringer representative, according to PR Newswire (10/25/12). Robert Heiden had toiled for Boehringer in Florida for some 14 years before becoming concerned over what he saw as illegal and inappropriate marketing practices that, in some instances, were thought to be endangering the health of patients.
The federal Whistleblower Act allows for whistleblower lawsuits to be brought by individuals against an alleged perpetrator on behalf of the government. In return, the whistleblower is awarded a portion of any monies recovered.
According to the report, the alleged Medicare fraud involved four drugs manufactured and marketed by Boehringer. In what was described as one of the most egregious examples of off-label marketing, the Boehringer drug Aggrenox carried FDA approval only for the prevention of secondary strokes. However, it was alleged that Boehringer promoted the use of Aggrenox as an effective drug to reduce the risk for heart attack and other cardiovascular risk in the absence of any substantive evidence to support such a claim.
In another example that fuelled the qui tam government whistleblower to pursue justice, Boehringer drugs Atrovent and Combivent were allegedly promoted to treat asthma and cough associated with colds and the flu in children, in spite of the fact neither drug had ever been tested for use with children.
Government whistleblowers, according to the Whistleblower Act, are entitled to an award of anywhere from 15 percent to 25 percent of any funds recovered. In this case, Heiden and his attorneys will receive in excess of 21 percent. While it is not known how much Heiden will receive after his legal team is paid, the total reward is about $20 million.
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"I was concerned that doctors were basing their treatment decisions on false information," Heiden said in a statement. "Promoting off-label treatments with potential serious consequences just to increase sales is heinous behavior."
Heiden filed his Qui Tam Whistleblower lawsuit under seal in federal district court in Baltimore seven years ago. After investigating Heiden's accusations, the government joined the case. It is not known if Boehringer was required to admit to any wrongdoing in the case.